BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Transvenous Temporary Phrenic Nerve Stimulator

    PMA: P240012 · Supplement: S004 · Decision Jan 14, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transvenous Temporary Phrenic Nerve Stimulator
    Trade Name
    AeroPace® System
    PMA Number
    P240012
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    SDL
    Generic Name
    Transvenous temporary phrenic nerve stimulator
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 14, 2026
    Date Received
    December 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two suppliers of PCBAs included in the assembly of the Neurostimulation Console and Handheld Controller.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDL Transvenous Temporary Phrenic Nerve Stimulator